GlaucomaPhase 4NCT01111890
Comparison of the Efficacy of AZARGA® Versus COSOPT® in Patients With Open-Angled Glaucoma or Ocular Hypertension
A Phase 4 study testing Azarga (brinzolamide 1% / timolol 0.5%) and Cosopt (dorzolamide 2% / timolol 0.5%) in people with Glaucoma and Ocular Hypertension, run by Alcon Research at 1 site in Canada.
Trial summary
Subjects are dosed twice daily at 9AM and 9PM for 12 weeks. The primary efficacy variable is the mean change in Intraocular Pressure (IOP) from baseline to 12 weeks. Secondary efficacy variable: % IOP ≤ 18 millimeters mercury (mmHg). Exploratory endpoint: Ocular discomfort scale after first dose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Ocular Hypertension
- What is being tested?
- Azarga (brinzolamide 1% / timolol 0.5%) and Cosopt (dorzolamide 2% / timolol 0.5%)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2010to Jul 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be at least 18 years of age.
- Must have a clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in at least one eye (study eye).
- Must have IOP considered to be safe, in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
- Must be willing to discontinue the use of all other ocular hypotensive agents prior to receiving the assigned study drug at Visit 1, throughout the study period.
- Must have an IOP of between 19 to 35 mmHg in at least one eye (which would be the study eye).
- For the eyes not included in the study, the intraocular pressure should be able to be controlled on no pharmacologic therapy or on the study medicine alone.
Who cannot join
- Known medical history of allergy, hypersensitivity or poor tolerance to any components of the preparations to be used in this study that is deemed clinically significant in the opinion of the Principal Investigator.
- Presence of other primary or secondary glaucoma not listed in inclusion criterion #2.
- Any abnormality preventing reliable applanation tonometry in study eye(s).
- Risk of visual field or visual acuity worsening due to participation in the study, in the investigator's best judgment.
- Progressive retinal or optic nerve disease from any cause.
- Use of systemic medications known to affect IOP (e.g., oral beta-adrenergic blockers, alpha-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers), which have not been on a stable course for 7 days prior to Day 1 Visit or an anticipated change in the dosage during the course of the study.
- A condition, which in the opinion of the Principal Investigator, would interfere with optimal participation in the study, or which would present a special risk to the subject.
- Participation in any other investigational study within 30 days prior to Visit 1.
Trial locations and contacts
1 site in 1 country.
About this study
Subjects are dosed twice daily at 9AM and 9PM for 12 weeks. The primary efficacy variable is the mean change in Intraocular Pressure (IOP) from baseline to 12 weeks. Secondary efficacy variable: % IOP ≤ 18 millimeters mercury (mmHg). Exploratory endpoint: Ocular discomfort scale after first dose.
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- Azarga (brinzolamide 1% / timolol 0.5%), Cosopt (dorzolamide 2% / timolol 0.5%)
- Medical subject headings
- Glaucoma, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azarga (brinzolamide 1% / timolol 0.5%)Drug
Dosed twice daily at 9:00 AM and 9:00 PM for 12 weeks
Cosopt (dorzolamide 2% / timolol 0.5%)Drug
Dosed twice daily at 9:00 AM and 9:00 PM for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Azarga | Experimental | Azarga (brinzolamide 1% / timolol 0.5%) Receives: Drug: Azarga (brinzolamide 1% / timolol 0.5%) |
| Cosopt | Active comparator | Cosopt (dorzolamide 2% / timolol 0.5%) Receives: Drug: Cosopt (dorzolamide 2% / timolol 0.5%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in Intraocular Pressure (IOP) following 12 weeks of twice daily dosing
Measured: 12 weeks
Secondary outcomes (1)
Percentage of subjects with IOP ≤ 18 millimeters mercury (mmHg)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01111890
- Sponsor's protocol ID
- SMA-09-17
- Status last verified
- Jan 2012
- First submitted
- 26 Apr 2010
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of AZARGA® Versus COSOPT® in Patients With Open-Angled Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT01111890
- Acronym / sponsor ID
- SMA-09-17
- Conditions
- Glaucoma, Ocular Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 28 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subjects are dosed twice daily at 9AM and 9PM for 12 weeks. The primary efficacy variable is the mean change in Intraocular Pressure (IOP) from baseline to 12 weeks. Secondary efficacy variable: % IOP ≤ 18 millimeters mercury (mmHg). Exploratory endpoint: Ocular discomfort scale after first dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azarga | Experimental | Drug: Azarga (brinzolamide 1% / timolol 0.5%)Azarga (brinzolamide 1% / timolol 0.5%) |
| Cosopt | Active comparator | Drug: Cosopt (dorzolamide 2% / timolol 0.5%)Cosopt (dorzolamide 2% / timolol 0.5%) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must be at least 18 years of age.
- Must have a clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in at least one eye (study eye).
- Must have IOP considered to be safe, in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
- Must be willing to discontinue the use of all other ocular hypotensive agents prior to receiving the assigned study drug at Visit 1, throughout the study period.
- Must have an IOP of between 19 to 35 mmHg in at least one eye (which would be the study eye).
Key exclusion criteria (8 listed)
- Known medical history of allergy, hypersensitivity or poor tolerance to any components of the preparations to be used in this study that is deemed clinically significant in the opinion of the Principal Investigator.
- Presence of other primary or secondary glaucoma not listed in inclusion criterion #2.
- Any abnormality preventing reliable applanation tonometry in study eye(s).
- Risk of visual field or visual acuity worsening due to participation in the study, in the investigator's best judgment.
- Progressive retinal or optic nerve disease from any cause.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azarga (brinzolamide 1% / timolol 0.5%)Dosed twice daily at 9:00 AM and 9:00 PM for 12 weeks | Drug | Azarga |
| Cosopt (dorzolamide 2% / timolol 0.5%)Dosed twice daily at 9:00 AM and 9:00 PM for 12 weeks | Drug | Cosopt |
Primary outcome
Mean change in Intraocular Pressure (IOP) following 12 weeks of twice daily dosing
Time frame: 12 weeks
1 secondary outcome
Percentage of subjects with IOP ≤ 18 millimeters mercury (mmHg)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Azarga (brinzolamide 1% / timolol 0.5%) and Cosopt (dorzolamide 2% / timolol 0.5%) in people with Glaucoma and Ocular Hypertension, run by Alcon Research at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in Intraocular Pressure (IOP) following 12 weeks of twice daily dosing (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2015.